FastThread Interference Screws

• Conditions: ACL Injury
• Interventions: Device: Arthrex FastThread Interference Screw

• Registration Number: NCT04689061
• Lead Sponsor: Arthrex, Inc.

Brief Summary

Surgery using the Arthrex PEEK or Biocomposite FastThread Interference Screw for ACL or PCL (PCL at US sites only, Biocomposite screw PCL only) repair or reconstruction.

Detailed Description

The objective of the study is to evaluate the continued safety and effectiveness of the PEEK and Biocomposite FastThread Interference Screws used for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) repair or reconstruction (PCL at US sites only, Biocomposite screw PCL only).

To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate effectiveness, patient reported outcomes will be collected at 3 months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS) for measuring pain in the affected knee and the Knee Injury and Osteoarthritis Outcome Score (KOOS) as well as Range of Motion (ROM, optional) for measuring knee functionality.

Study Timeline

• Study Start: 2020-08-31
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16
• Primary Completion: 2023-02
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subject requires surgery using the Arthrex PEEK Interference Screw for ACL or PCL (PCL at US sites only) repair or reconstruction or the Arthrex Biocomposite Interference Screw for PCL (PCL at US sites only) repair or reconstruction.
• Subject is 18 years of age or over.
• Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
• Subject signed informed consent and is willing and able to comply with all study requirements.

Exclusion Criteria

• Current bilateral injury of the ACL or PCL.
• Injury of the ACL and PCL in the same knee.
• Insufficient quantity or quality of bone.
• Blood supply limitations and previous infections which may retard healing.
• Foreign-body sensitivity.
• Any active infection or blood supply limitations.
• Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
• Subjects that are skeletally immature.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biocomposite FastThread Interference Screw	Arthrex FastThread Interference Screw	The absorbable Biocomposite Interference Screws combine the inherent degradation characteristics of a biocompatible polymer with the bioactivity of a ceramic. They are made of a combination of 70% poly (L-lactide-co-D, L-lactide) (PLDLA) and 30% biphasic calcium phosphate (BCP). The material has withstood the test of time with over a decade of clinical use and millions of implantations. It has been shown that the Biocomposite Interference Screw integrates well into the surrounding bone, produces little to no inflammatory response, and partially degrades 2 years after implantation

Primary Outcome Measures

Name	Time	Method
To assess change in Range of Motion (ROM)	preoperatively, 3 months, 6 months and 12 months post operative	Measuring knee functionality. (Flexion 0 to 130 degrees Extension 120 to 0 degrees
To assess change in Visual Analogue Scale (VAS)	preoperatively, 3 months, 6 months and 12 months post operative	Patient reported pain scale 0-10 point scale (0 min, 10 max)
To assess change in Knee Injury and Osteoarthritis Outcome Score (KOOS)	preoperatively, 3 months, 6 months and 12 months post operative	Patient reported outcome assessment. The interval score ranges from 0 to 100, (where 0 represents total knee disability and 100 represents perfect knee health)

Trial Locations

Locations (2)

Anderson Sports Medicine; 🇺🇸 Bingham Farms, Michigan, United States

Sportklinik Ravensburg; 🇩🇪 Ravensburg, Germany